Trial | NCT01191177  Report issue

Title

Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease
An Initial Trial of Enteral Fish Oil Supplementation in the Treatment of Parenteral Nutrition-associated Liver Disease in Patients With Short Bowel Syndrome

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    0
The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not
This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.
Study Started
Jan 31
2011
Primary Completion
Jan 31
2012
Anticipated
Study Completion
Jan 31
2012
Anticipated
Last Update
Jun 22
2017

Drug Lovaza (omega-3-acid ethyl ester)

supplied as 1gram transparent soft-gelatin capsules filled with yellow oil, dosage is 1gram per kilogram of body weight per day, not exceeding 4grams per day until normalization of liver function test

  • Other names: fish oil

Dietary Supplement Corn oil

1 gram per kilogram body weight per day, not exceeding 4 grams

Lovaza group Experimental

Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day

Placebo group Placebo Comparator

Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day

Criteria 

Inclusion Criteria:

History of parenteral nutrition(PN)administration >4weeks
PN associated liver disease from intestinal failure
ability to take full enteral feed
body weight equal or greater than 3kg
elevated ALT level twice of that normal(ALT>84)at the time PN is weaned off

Exclusion Criteria:

Hemodynamic instability
renal failure
suspected congenital obstruction of the hepatobiliary system
diagnosis hepatitis A, B, or C
diagnosis of alpha 1-antitrypsin deficiency
diagnosis of cytomegalovirus infection
diagnosis of HIV
children in care
No Results Posted